Premedication in paediatric patients: Dose finding study of clonidine administrated as nasal aerosol.

INTERVENTION: Trade Name: Clonidinehydroclorid solution Product Name: clonidinehydrochloride solution Pharmaceutical Form: Nasal spray, solution INN or Proposed INN: CLONIDINE HYDROCHLORIDE CAS Number: 4205918 Current Sponsor code: 1.0 Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: 600‐ Pharmaceutical form of the placebo: Nasal spray, solution Route of administration of the placebo: Nasal use CONDITION: Premedication prior to anaesthesia PRIMARY OUTCOME: Main Objective: To evaluate the dose of nasal administrated clonidine as an aerosol for preoperative sedation Primary end point(s): Comparison of median sedation scores between groups Secondary Objective: INCLUSION CRITERIA: 1. ASA class I and II patients 2. Patients between the age of 6 months and 6 years with a weight between 10 and 25 kilogram. 3. Planned for a surgical procedure at Astrid Lindgrens Childrens Hospital which require generell anaesthesia 4. Oral and written consent from the patient/parent Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18‐64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range